Medicines Acceptability in Hospitalized Children: An Ongoing Need for Age-Appropriate Formulations

Vallet, Thibault; Elhamdaoui, Omar; Berraho, A.; Cherkaoui, Lalla Ouafa; Kriouile, Yamna; Mahraoui, Chafiq; Mouane, Nezha; Pensé‐Lhéritier, Anne‐Marie; Ruiz, Fabrice; Bensouda, Y.

doi:10.3390/pharmaceutics12080766

Cited by 22 publications

(18 citation statements)

References 28 publications

(32 reference statements)

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“…Beyond RTIs, sublingual formulations should be of interest to provide suitable alternatives to solid oral dosage forms in preschoolers given the ongoing need for age-appropriate formulations in pediatrics, especially in younger children [ 11 ].…”

Section: Discussionmentioning

confidence: 99%

Acceptability of a Sublingual Drug Formulation for Respiratory Tract Infections in Children Aged 3 to 5 Years

Emeryk

Vallet²,

Wawryk‐Gawda

et al. 2021

Pharmaceutics

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In pediatrics, acceptability has emerged as a key factor for compliance, and consequently for treatment safety and efficacy. Polyvalent mechanical bacterial lysate (PMBL) in 50-mg sublingual tablets is indicated in children and adults for the prophylaxis of recurrent respiratory tract infections. This medication may be prescribed in children over 3 years of age; the appropriateness of this sublingual formulation should thus be demonstrated amongst young children. Using a multivariate approach integrating the many aspects of acceptability, standardized observer reports were collected for medication intake over the course of treatment (days 1, 2, and 10) in 37 patients aged 3 to 5 years, and then analyzed in an intelligible model: the acceptability reference framework. According to this multidimensional model, 50-mg PMBL sublingual tablets were classified as “positively accepted” in children aged 3 to 5 years on all three days of evaluation. As the acceptability evaluation should be relative, we demonstrated that there was no significant difference between the acceptability of these sublingual tablets and a score reflecting the average acceptability of oral/buccal medicines in preschoolers. These results highlight that sublingual formulations could be appropriate for use in preschoolers.

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Section: Discussionmentioning

confidence: 99%

Acceptability of a Sublingual Drug Formulation for Respiratory Tract Infections in Children Aged 3 to 5 Years

Emeryk

Vallet²,

Wawryk‐Gawda

et al. 2021

Pharmaceutics

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“…In this study cefaclor fine granules appeared to be well-accepted in all age groups, even in infants and toddlers. Important acceptability issues have been highlighted in those young patients using the same standardized assessment method in other culture [ 20 ]. Further explorations are needed to better understand how medicine acceptability may vary across countries depending on sociocultural aspects.…”

Section: Discussionmentioning

confidence: 99%

“…This study approved by the Ethics Committee of NCCHD (2019-081) was conducted on a voluntary basis in patients less than 18 years old treated with any oral/buccal medicine. To explore acceptability, we used a validated data-driven approach simultaneously considering the many aspects of this multi-faceted concept [ 18 , 19 , 20 , 21 ]. This article focuses on findings on cefaclor fine granules.…”

Section: Methodsmentioning

confidence: 99%

Adherence and Acceptability of an Oral Antibiotic Used for the Prevention of Pediatric Urinary Tract Infection in Japan

et al. 2021

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Urinary tract infection (UTI) is a common health care-associated adverse event and the leading nosocomial complication following pediatric urological surgery. While continuous antimicrobial prophylaxis effectively reduces the risk of UTI following such a surgery, non-adherence is common and represents a distinct clinical entity that is associated with renal scarring. Acceptability is likely to have a significant impact on patient adherence. Herein we used a validated data-driven approach—the ClinSearch acceptability score test (CAST)—to investigate the acceptability of cefaclor, an oral antibiotic widely used for the prevention of pediatric UTI in Japan. Standardized observer reports were collected for 58 intakes of cefaclor 10% fine granules in patients aged from 0 to 17 years. The medicine was classified as positively accepted on the acceptability reference framework. According to the percentage of the prescribed dose taken reported at the end of the treatment, patients exhibited good adherence to this well-accepted medicine. Nonetheless, requirements for greater dosing frequency or poor acceptability in certain patients could affect adherence. Acceptability should be established to ensure patient adherence to medicines used for long-term prophylaxis and consequently guarantee the safety and efficacy of the treatment.

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“…Data were collected at home and at hospital in France (May 2015–December 2020); at hospital in Morocco (November 2018–February 2020), the United-Kingdom (June 2019–April 2021), Japan (June 2019–July 2021), India (August 2019–January 2021) and Germany (August 2020–June 2021); at home in Norway (May 2018–June 2021), Poland (July 2020) and Peru (May 2021–June 2021). The ClinSearch Acceptability Score Test (CAST), a standardized and validated tool, was used to explore medicine acceptability drivers [ 25 , 26 , 27 , 28 , 29 , 30 ]. The published methodology is briefly described in the following subsections.…”

Section: Methodsmentioning

confidence: 99%

“…Herein we used a multivariate approach [ 25 , 26 , 27 , 28 , 29 , 30 ] mining a large set of international real-life data to explore acceptability drivers of oral antibiotics in children.…”

Section: Introductionmentioning

confidence: 99%

Exploring Acceptability Drivers of Oral Antibiotics in Children: Findings from an International Observational Study

Vallet¹,

Bensouda

Saito

et al. 2021

Pharmaceutics

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Antibiotics are among the most commonly prescribed drugs in children. Adherence to the treatment with these drugs is of the utmost importance to prevent the emergence of resistant bacteria, a global health threat. In children, medicine acceptability is likely to have a significant impact on compliance. Herein we used a multivariate approach, considering simultaneously the many aspects of acceptability to explore the drivers of oral antibiotic acceptability in children under twelve, especially in toddlers and in preschoolers. Based on 628 real-life observer reports of the intake of 133 distinct medicines, the acceptability reference framework highlighted the influence of many factors such as age and sex of patients, previous exposure to treatment, place of administration, administration device, flavor agent in excipients and active pharmaceutical ingredient. These findings from an international observational study emphasize the multidimensional nature of acceptability. Therefore, it is crucial to consider all these different aspects for assessing this multi-faceted concept and designing or prescribing a medicine in order to reach adequate acceptability in the target population.

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Medicines Acceptability in Hospitalized Children: An Ongoing Need for Age-Appropriate Formulations

Cited by 22 publications

References 28 publications

Acceptability of a Sublingual Drug Formulation for Respiratory Tract Infections in Children Aged 3 to 5 Years

Acceptability of a Sublingual Drug Formulation for Respiratory Tract Infections in Children Aged 3 to 5 Years

Adherence and Acceptability of an Oral Antibiotic Used for the Prevention of Pediatric Urinary Tract Infection in Japan

Exploring Acceptability Drivers of Oral Antibiotics in Children: Findings from an International Observational Study

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